← Back to Search

Radioprotector

RadProtect for Radiation Protection

Phase 1
Waitlist Available
Research Sponsored by Original BioMedicals Co. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or woman of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during screening, while receiving the investigational drug, and for 60 days after stopping the investigational drug
Healthy volunteer subjects of both genders, aged 18-64 years old, and any race/ethnicity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 ~ day 1 (24 hours after dosing)
Awards & highlights

Study Summary

This trial is testing a new drug, RadProtect, to see if it is safe and tolerated by healthy volunteers. The trial will be conducted at two clinical centers.

Who is the study for?
Healthy adults aged 18-64 with normal blood pressure and BMI of 18-30 kg/m^2 can join. They must not have diabetes, heart, liver, or kidney diseases, active cancer, or certain other conditions. Participants need to use reliable contraception and avoid other trials or experimental treatments.Check my eligibility
What is being tested?
The trial is testing RadProtect®, a new drug for preventing radiation injury. It's an early-stage study where volunteers receive increasing doses to check the drug's safety and how it moves through the body over time.See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety and dosage levels in healthy volunteers, specific side effects are being investigated but are not yet listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using effective birth control and will continue for 60 days after the trial.
Select...
I am a healthy volunteer aged 18-64.
Select...
My BMI is between 18 and 30.
Select...
I can understand and participate in phone and in-person visits for the study.
Select...
I am of childbearing age and my pregnancy test was negative.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 ~ day 1 (24 hours after dosing)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 ~ day 1 (24 hours after dosing) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.
Secondary outcome measures
Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RadProtect®Experimental Treatment1 Intervention
RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine. Transferrin and other related proteins can chelate with ferrous iron and break the micelle releasing amifostine into the blood stream.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Original BioMedicals Co. Ltd.Lead Sponsor

Media Library

RadProtect® (Radioprotector) Clinical Trial Eligibility Overview. Trial Name: NCT02587442 — Phase 1
Acute Radiation Syndrome Research Study Groups: RadProtect®
Acute Radiation Syndrome Clinical Trial 2023: RadProtect® Highlights & Side Effects. Trial Name: NCT02587442 — Phase 1
RadProtect® (Radioprotector) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02587442 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible for enrollment in this research investigation?

"This clinical trial is seeking 27 participants, between ages 18 and 64, who are currently experiencing the effects of acute radiation syndrome. In addition to this parameter, candidates must also adhere to the following criteria: normal blood pressure (ranging from 120-140/60-80mmHg), be individuals of childbearing potential using adequate contraception during screening and treatment, provide written consent for the study, possess a body mass index ranging from 18-30kg/m2 with negative pregnancy test results at screening where applicable, demonstrate physiological examination and laboratory values within healthy parameters on CBC/differential tests as well as iron levels TIBC urinalysis EC"

Answered by AI

Does this research endeavor include participants aged 45 and older?

"People aged between 18 and 64 are being recruited for this trial."

Answered by AI

Has RadProtect® obtained the FDA's stamp of approval?

"The safety rating of the RadProtect® product is a 1, as it has yet to be tested extensively in clinical trials."

Answered by AI

Are people currently being recruited to participate in this clinical trial?

"Clinicaltrials.gov records indicate this trial is not currently open for recruitment, despite having been posted on October 1st 2015 and updated 26 days later in the same month. Happily, 10 other trials are actively recruiting patients at present."

Answered by AI
~3 spots leftby Mar 2025